Prostate CancerPhase 4NCT02149628
The Effect of Propofol Based Total Intravenous Anesthesia on Oxidative Stress and Nitric Oxide
A Phase 4 study testing propofol and Desflurane in people with Prostate Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Robot assisted laparoscopic radical prostatectomy(Robot-LRP) requires pneumoperitoneum and trendelenburg position which result in oxidative stress and inflammatory response. Propofol is well known to reduce those responses during anesthesia. Read more about this study
- Who is it for?
- Ages 20 to 70 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- propofol and Desflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Feb 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing robot-assisted laparoscopic radical prostatectomy under general anesthesia
Who cannot join
- chronic renal failure ( estimated glomerular filtration rate <60 mL/min/1.73m2)
- allergy to propofol, nuts
- on diuretics, vitamin C or vitamin E within 5 days before surgery
- Body mass index > 30 kg/m2
- older than 70 years
- who cannot read the patient consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Propofol Based Total Intravenous Anesthesia on Oxidative Stress and Nitric Oxide in Patients Undergoing Laparoscopic Surgery
Robot assisted laparoscopic radical prostatectomy(Robot-LRP) requires pneumoperitoneum and trendelenburg position which result in oxidative stress and inflammatory response.
Propofol is well known to reduce those responses during anesthesia. Therefore, we try to figure out the efficacy of propofol to reduce oxidative stress, inflammatory response and increase the nitric oxide activity during robot-LRP compared to that of desflurane.
Read more
To investigate the oxidative stress, malondialdehyde will be measured. As inflammatory markers, interleukin-1β, interleukin-6, tumor necrosis factor-α will be measured. Nitric oxide will be measured as well.
Secondarily, kidney protection effect of propofol over desflurane will be compared.
- Conditions
- Prostate Cancer
- Being tested
- propofol, Desflurane
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Also called fresofol, 2%
DesfluraneDrug
| Study group | Role | What they receive |
|---|---|---|
| desflurane | Active comparator | use desflurane as a primary anesthetics during anesthesia guided by bispectral index (BIS) Receives: Drug: Desflurane |
| propofol | Experimental | propofol infusion with target-controlled infusion(TCI) device guided by BIS Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of serum malondialdehyde, Interleukin-1β, interleukin-6, tumor necrotic factor-α, nitric oxide during operation
Measured: 100 min after pneumoperitoneum, 10 min after decompression
Secondary outcomes (1)
kidney function after anesthesia
measure creatinine
Measured: 1 day after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Goun Roh, MD, Principal investigator, Yonsei University Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149628
- Sponsor's protocol ID
- 3-2013-0098
- Status last verified
- Jul 2015
- First submitted
- 19 May 2014
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Propofol Based Total Intravenous Anesthesia on Oxidative Stress and Nitric Oxide in Patients Undergoing Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT02149628
- Acronym / sponsor ID
- 3-2013-0098
- Conditions
- Prostate Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Robot assisted laparoscopic radical prostatectomy(Robot-LRP) requires pneumoperitoneum and trendelenburg position which result in oxidative stress and inflammatory response.
Propofol is well known to reduce those responses during anesthesia. Therefore, we try to figure out the efficacy of propofol to reduce oxidative stress, inflammatory response and increase the nitric oxide activity during robot-LRP compared to that of desflurane.
To investigate the oxidative stress, malondialdehyde will be measured. As inflammatory markers, interleukin-1β, interleukin-6, tumor necrosis factor-α will be measured. Nitric oxide will be measured as well.
Secondarily, kidney protection effect of propofol over desflurane will be compared.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| desflurane | Active comparator | Drug: Desfluraneuse desflurane as a primary anesthetics during anesthesia guided by bispectral index (BIS) |
| propofol | Experimental | Drug: propofolpropofol infusion with target-controlled infusion(TCI) device guided by BIS |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing robot-assisted laparoscopic radical prostatectomy under general anesthesia
Key exclusion criteria (6 listed)
- chronic renal failure ( estimated glomerular filtration rate <60 mL/min/1.73m2)
- allergy to propofol, nuts
- on diuretics, vitamin C or vitamin E within 5 days before surgery
- Body mass index > 30 kg/m2
- older than 70 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofolAlso: fresofol, 2% | Drug | propofol |
| Desflurane | Drug | desflurane |
Primary outcome
changes of serum malondialdehyde, Interleukin-1β, interleukin-6, tumor necrotic factor-α, nitric oxide during operation
Time frame: 100 min after pneumoperitoneum, 10 min after decompression
1 secondary outcome
kidney function after anesthesia
Time frame: 1 day after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Goun Roh, MD principal investigator
Yonsei University Gangnam Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing propofol and Desflurane in people with Prostate Cancer, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of serum malondialdehyde, Interleukin-1β, interleukin-6, tumor necrotic factor-α, nitric oxide during operation (time frame: 100 min after pneumoperitoneum, 10 min after decompression). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2015.